# K120741: Voluson S6, Voluson S8

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Apr 27, 2012 after 46 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K935595 (1995). 115 ancestors in all.
295 later devices descend from it; 5 cite it directly.
0 of 411 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103649: Voluson S6, Voluson S8, GE Healthcare (2011) Summary page 1.
- K113758: Voluson E6/E8/E8EXPERT/E10, GE Healthcare (2012)
- K112213: Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System, GE Healthcare (2011)
- K053435: GE Voluson I, General Electric Co. (2005) Summary page 1.
- K113690: GE Logiq I, Logiq E and Vivid E, GE Healthcare (2011) Summary page 1.

## Most influential descendants
- K131267: Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 (2013), 270 descendants of its own
- K132913: Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 (2013), 255 descendants of its own
- K122387: Voluson P6, Voluson P8 (2012), 201 descendants of its own
- K142472: Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems (2015), 187 descendants of its own
- K133034: Logiq F Series (2014), 155 descendants of its own

## Indications for use
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

Source page: https://510kreport.com/device/K120741
Methodology: https://510kreport.com/methodology